Rules that govern advertising and promotion activities of medicines and medical devices in Portugal have been changed recently by the enactment of Decree-Law 5/2017 of 6 January (“Decree-Law 5/2017”).
This new legal act establishes principles that shall be accomplished by marketing authorization holders and distributors of medicines, as well as manufacturers and distributors of medical devices in their advertising and promotion activities.
Decree-Law 5/2017 further provides legal changes that strengthen transparency requirements in the relationships between pharmaceutical industry and medical devices industry, on one side, and healthcare practitioners and healthcare organisations, on the other.
The promotion of good governance practices in health sector is a demand of society and has been a trend that motivated the approval of specific legislation in several countries to tackle the issue of conflicts of interest in the relationships between the industry and the healthcare professionals. The EU Commission initiative on Ethics & Transparency in the pharmaceutical sector, as well as the approval of guidelines in this subject matter by the industry’s representative organisations, notably by EPFIA and MedTech Europe, are noteworthy examples of this trend.
The prevention of conflicts of interest situations in the interactions between players of the industry of medicinal products and medical devices and healthcare professionals and healthcare organizations is also a matter of utmost importance for the Portuguese legislator. The Portuguese Law sets forth transparency requirements in the relations between players of pharma industry and healthcare professionals and organizations since 2013, providing for disclosure obligations of donations, grants or benefits of more than EUR 60,00 in an electronic platform displayed in the Medicines Agency, Infarmed’s, website. The newly enacted Decree-Law 5/2017 further strengthens such requirements.
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Source: Global Compliance News – Rita Roque de Pinho is an Of Counsel at pbbr in Lisbon, Portugal.